[Code of Federal Regulations]
[Title 21, Volume 1, Parts 1 to 99]
[Revised as of April 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.20]

[Page 246]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
PART 50--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
              Subpart B--Informed Consent of Human Subjects
 
Sec. 50.20  General requirements for informed consent.

    Source:  46 FR 8951, Jan. 27, 1981, unless otherwise noted.


    Except as provided in Sec. 50.23, no investigator may involve a 
human being as a subject in research covered by these regulations unless 
the investigator has obtained the legally effective informed consent of 
the subject or the subject's legally authorized representative. An 
investigator shall seek such consent only under circumstances that 
provide the prospective subject or the representative sufficient 
opportunity to consider whether or not to participate and that minimize 
the possibility of coercion or undue influence. The information that is 
given to the subject or the representative shall be in language 
understandable to the subject or the representative. No informed 
consent, whether oral or written, may include any exculpatory language 
through which the subject or the representative is made to waive or 
appear to waive any of the subject's legal rights, or releases or 
appears to release the investigator, the sponsor, the institution, or 
its agents from liability for negligence.